Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014409527

FEI Number

3014409527

Entity Name

INTHESMART CO., LTD.

City/State/Country

JONGRO-GU Seoul, KR

Establishment Address

Center for Medical Innovation (CMI) Bld. 71 DAEHAK-RO, JONGRO-GU Seoul 03082, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

InTheSmart Co., Ltd. (Owner Number: 10057252)

Owner / Operator Contact Address

Center for Medical Innovation (CMI) Bld. 71 DAEHAK-RO, JONGRO-GU, KR-11 03082, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ITSEL1711

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FCQ	Light Source, Incandescent, Diagnostic	Gastroenterology, Urology	Class 2	876.1500	2018-03-15

Official Correspondent

Jina Nam

US Agent Details

Yoseph Kim Business: OPTOSURGICAL LLC. Email: yoseph.kim@optosurgical.com Phone: (203) 6757089

Related Public Records

Same Entity

InTheSmart Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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3012404174	LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL.	Schio Vicenza, IT
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3043617526	AD SCIENTIAM	Paris Ile-de-France, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014409527. Last updated year: 2026. Please use registration number 3014409527 when referencing this establishment in official correspondence.